Some medicaments are delivered to the patients in solid form, other in liquid form. Often, the liquid medicaments are delivered in a container. Some container consists only or mainly of glass, other consists only or mainly of other materials such as plastic.
Medicaments in solid form are often marketed in a glass container or a plastic container. An example of a plastic container is a blister package.
In a pharmaceutical composition in liquid form, the active ingredient is present in dissolved or suspended form. In addition to the active ingredient, a pharmaceutical composition may contain a pharmaceutically active carrier, a disintegrater, a stabalizer, or a buffer substance.
The route of administration varies between the different medicaments. Some medicaments are administered via the oral route, other are administered by injecting the medicament to the patient, for example, intravenously or subcutaneously. Many medicaments being peptides, for example, insulin, are administered by injections. Earlier, syringes were used for the injections. As far as insulin is concerned, it is becoming more and more common to use so called pen systems for the injections. Furthermore, the use of pumps for administration by injection may become a popular way of administrations by injections. In some of the pumps, the aqueous composition will be present in a glass reservoir or another hard reservoir, in other pumps, aqueous compositions will be present in a flexible reservoir, for example a reservoir which is wholly or mainly made of another material than glass, for example of plastic.
For many aqueous compositions, it is extremely difficult to find a non-glass material which can safely be used to store said aqueous composition until it is used by the patient. One of the many difficulties is the high mobility of preservatives in welding layer based on polymers like polyethylene (herein designated PE), polypropylene (herein designated PP), polyethylene terephtalate (herein designated PET) or the like combined with a high affinity of the preservatives to the widely used adhesives based on polyurethane used for lamination of welding layer to a moist barrier like polychlorotrifluoroethylene (herein designated PCTFE). The result of tests of the known art plastic products containing a solution of a medicament with preservatives is that a fast and not desired reduction in the content of preservative in the medicated solution takes place. A main task for the inventors of this invention has been to find a material or combination of materials which can be used to prepare a transparent, flexible container fulfilling the safety requirements for storage of pharmaceutical solutions containing a preservative such as phenol, m-cresol and benzyl alcohol. It was extremely difficult to find a material fulfilling these requirements.
Briefly, the object of this invention is to overcome or ameliorate at least some of the disadvantages of the prior art. Hence, not all the objects mentioned below may be fully overcome or ameliorated.
A more specific object of this invention is to furnish a container or reservoir.
Another object of this invention is to furnish a flexible container.
Another object of this invention is to furnish a transparent container.
Another object of this invention is to furnish a part allowing sterilization.
Another object of this invention is to furnish materials which may be welded to itself to form the above mentioned reservoir.
Another object of this invention is to furnish a container which can be used for storage of liquid solutions or suspensions of medicaments, optionally containing preservatives.
Another object of this invention is to furnish a container which has a sufficient transparency so as to enable inspection of the content of the container.
Another object of this invention is to furnish a container which can be used to storage of liquid solutions or suspensions of medicaments, optionally containing preservatives and which container not or only to a minor degree consists of glass.
Another object of this invention is to furnish a container having barrier properties securing that the concentration of the active ingredient in the aqueous composition is not changed substantially during storage for a sufficient period of time.
Another object of this invention is to furnish a container having barrier properties securing that the concentration of any preservative present in the aqueous composition is not changed substantially during storage for a sufficient period of time.
Another object of this invention is to furnish a container which can be welded tightly against a suitable septum material.
Another object of this invention is to furnish a container which can be adhered tightly against a suitable septum material by other means than welding.
A further object of this invention is to furnish a film for a pouch which can be used for storage of sterile water based drug formulation.
A further object of this invention is to furnish a pouch which can be used as reservoir for a pump and, preferably, said reservoir contains a water based drug formulation.
A further object of this invention is to furnish a film material for said pouch fulfilling certain functional requirements such as physical properties for the material after sterilization, chemical requirements for the material after sterilization, and cleanliness.
Hence, one object of this invention is to furnish a film material for said pouch which can be sterilized, for example, using gamma irradiation, electron beam, steam, or ethylene oxide.
A further object of this invention is to furnish a film material for said pouch which, after sterilization, fulfills most of or all the following physical requirements: 1) the material must be transparent, 2) the material must provide a good barrier against water; 3) the material must provide a good barrier against gasses (for example, oxygen and carbon dioxide); 4) the material must provide a good barrier against preservatives (for example, phenol and meta-cresol); 5) the material must provide a good barrier against odors (for example preservatives); 6) the material must be resistant against environmental stress cracking (for example, oils, perfumes); 7) the material must be resistant against flex-crack; 8) the material must have good sealing properties (for example, by welding); 9) the material must not delaminate after sterilization, during processing or storage; and 10) the material must not relax significantly during storage and use.
A further object of this invention is to furnish a film material for said pouch which, after sterilization, fulfills most of or all the following chemical requirements: 1) the material must not emit substances to the drug which can affect the health and safety of the patient (leachables); 2) the material must have a very low level of extractables; and 3) the material must be compatible with the drug formulation.
A further object of this invention is to furnish a film material for said pouch which, after sterilization, fulfills the following requirements for cleanliness: 1) it shall be possible to prepare the material under hygienic conditions; and 2) the final product must be free of dust and particles.
A further object of this invention is to furnish a film for said pouch fulfilling certain health and safety requirements, preferably most of or all the requirements mentioned in 1) European Pharmacopoeia (Ph. Eur.) 2002, 4th edition; 2) The United States Pharmacopeia (USP) 25; 3) Japanese Pharmacopeia (JP) XIV; 4) EEC Directive 90/128+amendments “Relating to plastics materials and articles intended to come into contact with foodstuffs”; 5) Code of federal regulations (CFR) Title 21 Food and Drugs, part 170-190; 6) III /9090/90 EN. Plastic Primary Packaging Materials. Note for Guidance; and 7) Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics, Chemistry, Manufacturing, and Controls Documentation. FDA, May 1999.